Pharmacy Purchasing & Products: In light of proposed USP Chapter <800>, how should an organization approach CSTD implementation and training? Seth Eisenberg: Facilities that currently do not use a closed system drug-transfer device (CSTD) should initiate a comparative evaluation to identify which device best suits the needs of the organization. The vetting process should include pharmacy and nursing because experience has taught us that the device that best suits one group may be less than ideal for the other. In some cases, a facility may consider purchasing two different devices, with one used for compounding and the other for administration. Although not the most cost-effective solution, this approach can ensure that each department’s needs are met.

Once a device has been selected, pharmacy and nursing should enlist CSTD champions. Nursing champions, or super-users, should include staff nurses who are directly involved with the administration of hazardous drugs (HDs), in addition to clinical nursing specialists and educators. Begin staff education with the rationale behind the implementation of the devices, lest they be dismissed as an unnecessary bureaucratic requirement. Hands-on education with the device should be coordinated with the manufacturer’s representatives, as these individuals are the most familiar with the devices and can demonstrate proper use and troubleshoot any challenges that arise. Pharmacy and nursing champions should work alongside the manufacturer’s representative to address any workflow concerns.

Every nurse who works with HDs should receive hands-on training to become familiar with the product and its unique features. This includes part-time, per diem, and float nurses who work in oncology units, as well as any other staff that administers non-antineoplastic HDs in other areas of the hospital. It is vitally important that all staff establish their competence using the devices prior to administering HDs, as failure to do so may result in spills upon implementation.

Firouzan Massoomi: CSTD implementation and training must be grounded in a clear understanding of the safety hazards associated with improper HD handling; without an understanding of the risks, CSTD training likely will be for naught as best practices may not be maintained.

Once staff members are educated on the potential risks, review current and proposed regulations. Educators should provide staff with an overview of USP <797>, proposed USP <800>, and NIOSH HD handling guidelines. Prior to any CSTD manipulation, staff must demonstrate competence in manipulating sterile products; thereafter, hands-on CSTD training can commence.

PP&P:What are the key elements of a CSTD training program?Massoomi: First, staff must understand how the CSTD works, as it differs from using a needle and syringe. Training also should include discussion about how the CSTD provides HD containment and prevents exposure to the environment and the user.

Another topic for discussion is the device’s potential failure points. Establish a contingency plan that outlines the steps to take if the device fails to operate as intended. While CSTDs work correctly the majority of the time, the risk of failure exists. If failure occurs, it is important to report the event to the FDA. Historically, pharmacy has not made reporting device failures a priority. For example, if a CSTD component does not operate as intended, users often will simply set it aside and move on. The benefit of reporting these events is that FDA then has access to accurate information if a batch is produced improperly and a recall is required.

Eisenberg: Training on the various components of the device will differ for nurses and pharmacists. Vial adaptor components, for example, are not relevant for nurses, as they typically are not involved in compounding. Instead, nurses interface with CSTD components that pertain to the various phases of HD administration. The first is connecting the IV bag to the tubing. HDs are sent to the nursing units in several ways, but, in general, nurses either attach neutrally primed tubing directly to the IV bag, which has the CSTD already attached, or they attach tubing that already has been connected to the IV bag in the pharmacy (a short secondary line) to a longer primary line that has been primed with neutral solution. In the latter scenario, a CSTD is attached to the end of the tubing to prevent drips from occurring during disconnect.

A key component of drug administration is properly disconnecting the IV tubing from the patient. Prior to disconnection, the tubing typically will be flushed with a neutral solution. Depending on the setup, this can involve the use of a primary line, or back-flushing via the CSTD at the bag itself. If it is determined that the latter will be the preferred method of flushing, then the appropriate CSTD components need to be utilized, along with the requisite inservicing to understand how to flush the system.

For HDs administered in a syringe, the CSTD arrives from the pharmacy already attached, which prevents leakage during transport and avoids the possibility of a nurse forgetting or electing not to attach the device.

PP&P: What techniques are the most useful to illustrate during training?Eisenberg:Actual hands-on CSTD training that uses surrogate substances (eg, liquids with food-coloring) in IV bags, syringes, and tubing, and that simulates real-world HD administration, is important to help staff learn appropriate HD handling and CSTD use. Training should encompass all phases and routes of HD administration, including subcutaneous, intramuscular, and intraperitoneal, if performed.

Massoomi: The most effective way to help staff become comfortable with a CSTD is hands-on practice. Whether you are moving from a syringe and needle method to a CSTD, or from one CSTD to another, staff requires education on the differences between the methods. Have staff members perform both methods back-to-back to demonstrate how the new method differs from the old, and provide a question and answer period to facilitate discussion. Issues that should be addressed include: Is the device intuitive and easy to use? Does using this device minimize repetitive strain injury? After the best device has been identified, one final question must be answered: Does this device/process make me feel safe or safer than the current process?

PP&P: What are some common pitfalls to avoid in CSTD training?Massoomi: One of the most challenging aspects of implementing a CSTD and training staff is overcoming resistance to change. Opposition to new processes is common, even when it is clear that the new method is safer than that which it is replacing. Familiarity and routine often weigh heavily on individuals performing critical tasks, such as compounding and administering HDs. Mapping out safety concerns of existing systems (eg, needle sticks, spills, previous device failures) and identifying inefficiencies (eg, pressure equalization, spill cleanup) help staff see the benefits to incorporating a new device and processes. Without staff input and critique of existing processes, the change will be perceived as another management-driven initiative.

Additional pitfalls in CSTD training include:

Failure to Fully Evaluate the Available CSTDs In-House. Pharmacy and nursing staff should evaluate CSTDs thoroughly, laying out all touch points associated with hazardous handling and defining where a CSTD can enhance safety programs; do not simply accept information supplied by vendors.

Not Including Pharmacy and Nursing in the Evaluation Process. Remember the CSTD that works best for compounding is not necessarily the device that will be the most intuitive for nursing. If nursing views the CSTD as too cumbersome, a danger arises that nurses will remove the device, negating the potential safety benefits.

Eisenberg: Some common problems with CSTD training include:

Scheduling Insufficient Training Time. Be sure to allow adequate hands-on time with the device.

PP&P: How can training communicate to pharmacy and nursing that ensuring safe HD practices is a shared responsibility? Eisenberg:Clearly written policies and procedures, which detail how and when the devices are to be used, are the foundation for a successful CSTD implementation. Training should reflect policy, and policy should support training. Although nursing and pharmacy interact with different parts of the closed system, nursing relies upon pharmacy to compound HDs in accordance with policy. If an HD mistakenly leaves the IV room without the requisite CSTD, the nurse is unable to administer the drug to the patient without violating nursing policy, and the likelihood of exposure is increased.

Similarly, pharmacy departments go to great lengths to ensure containment of the HD during compounding, transport, and administration. If a nurse fails to use the device during administration, this undermines the principle of keeping the HD contained at all times. Furthermore, should a major spill occur because a nurse elects not to use a CSTD, pharmacy is then required to prepare a replacement bag. This requires additional workflow and added expense, which is even more significant in the face of current antineoplastic drug shortages. In addition to contaminating the environment, a spill also generates added work, which is likely to impact multiple departments, related to the spill response.

Massoomi: When we included nurses in CSTD training, it became apparent that they did not have a clear understanding of pharmacy’s workflow for preparing hazardous medications. Conversely, our pharmacy technicians had limited knowledge of nursing’s workflow during drug administration. Therefore, we had both groups observe the other throughout every step required for drug preparation, administration, and waste. We found this was vital to each group understanding CSTD use by the other group. Through this multidisciplinary job shadowing process, appreciation for each health care provider’s role in the HD safety program was elevated.

Clearly, choosing a CSTD in collaboration with nursing is critically important, as a device cannot protect users from HD exposure if it is not used. Following our initial CSTD implementation, we assumed nurses were using the devices as intended. We were surprised to discover during rounds that many nurses found the devices cumbersome and consequently removed them prior to administration at the patient’s bedside. When we identified concerns from nursing regarding how cumbersome the administration process was, we engaged the vendor’s representative to ensure our process was correct. Ultimately, we determined that the CSTD we had collectively selected would not meet nursing’s needs. We chose to use a hybrid system utilizing two CSTDs to meet the needs of both pharmacy and nursing and, thereby, developed a collaborative solution that assures safety at each step of the process.

PP&P: How can an organization improve its overall culture of safety? Massoomi:Appropriate pharmacy and nursing education detailing the risks of HD use is critical to ensure that a culture of safety flourishes. Staff members need to understand that the protections that have been put in place are specifically designed to protect their health.

Moreover, it is critical to educate hospital administrators and the HR department by emphasizing how ensuring employees’ safety also protects the business. Labor laws exist to protect employees; staffers have a legal right to file a lawsuit against their employer if the hospital is not providing the requisite education and PPE to ensure safety. Proposed USP Chapter <800> discusses the requirements of a hazard communication program and personnel training (see SIDEBAR).

Eisenberg: HD education is clearly a cornerstone of ensuring a culture that emphasizes safety. Such an environment cannot evolve without an understanding of the inherent dangers. Acknowledging the risks associated with HD handling is a prerequisite for establishing a best practice approach to safety. Likewise, understanding the risks provides the rationale for expected behaviors.

The cultural priorities of a workplace generally spread from the top down, so consider: Is safety a priority for the organization? How does the unit manager view HD risk? Facilities that do not provide the required PPE, for example, send an unfavorable message about their safety culture.

Also, it is important to revisit HD risks on a regular basis. A topic discussed only during new employee orientation does not carry the same weight as one that is revisited, even briefly, at regular intervals.

Unit champions can help set expectations at the bedside by exhibiting consistent behavior. Nurses who initially do not comply with the policy should be approached by their peers to help them understand the importance of adherence. In this way, adherence becomes the cultural norm. Examples of appropriate behavior should start with management; otherwise, staff members receive an inconsistent message and begin to question the importance of the issue.

For staff members who refuse to adhere to policy, consequences must be established. Staff members who witness other employees regularly violating policy without consequence will begin to question the importance of the policy. While disciplinary action should be considered a last resort, it affirms the organization’s commitment to making safety a priority.

Firouzan “Fred” Massoomi, PharmD, FASHP, received his doctorate from the University of Kansas School of Pharmacy and is the pharmacy operations coordinator at the Nebraska Methodist Hospital in Omaha. He currently serves on the Nebraska Pharmacists Association Board of Directors.

Seth Eisenberg, RN, OCN, BMTCN, professional practice coordinator for infusion services at the Seattle Cancer Care Alliance Ambulatory Clinic, has worked in the field of oncology since 1983. His experience includes 29 years in hematopoietic stem cell transplantation associated with the Fred Hutchinson Cancer Research Center.

Hazard Communication ProgramEntities are required to establish policies and procedures that ensure worker safety during all aspects of HD handling.* The entity must develop SOPs to ensure effective training regarding proper labeling, transport, and storage of the HDs and use of Safety Data Sheets (SDS), based on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).Elements of the plan must include:

A written plan that describes how the standard will be implemented.

All containers of hazardous chemicals must be labeled, tagged, or marked with the identity of the material and appropriate hazard warnings.

Entities must have an SDS for each hazardous chemical they use.

Entities must ensure that the SDSs for each hazardous chemical used are readily accessible to personnel during each work shift and when they are in their work areas.

Personnel who may be exposed to hazardous chemicals when working must be provided information and training before the initial assignment to work with a hazardous chemical, and also whenever the hazard changes.

Personnel TrainingAll personnel who handle HDs must be fully trained based on their job functions (eg, in the receipt, storage, handling, compounding, dispensing, and disposal of HDs). Training must occur before the employee independently handles HDs. The effectiveness of training for HD handling competencies must be demonstrated by each employee. Personnel competency must be reassessed at least every 12 months and when a new HD or new equipment is used or a new or significant change in process or SOP occurs. All training and competency assessment must be documented.

*In accordance with the Occupational Safety and Health Administration’s Hazard Communication Program. Proposed USP <800> has built on the requirements of OSHA and updated them into elements of a plan as it relates to the handling of HDs.

Information available at: OSHA Fact Sheet. Steps to an Effective Hazard Communication Program for Employers That Use Hazardous Chemicals. https://www.osha.gov/Publications/OSHA3696.pdf.

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